Solara CRT-P MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Pacemaker (CRT-P) · First cleared Mar 2011
Total Reports
207
Reports (30d)
3
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Failure with Device Explanted
explanted, pacing, right, ventricular, lead
5
reports
No Allegations on Device Received
successfully replaced, premature, noise, observed, field
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Apr 6, 2021 · Open, Classified
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
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